Quality Assurance Engineer at Staar Surgical

Job description

OBJECTIVE AND MAIN TASK OF THE FUNCTION - Lead and drive Non-Conformance investigations for components, finished goods, and product returns. - Perform impact assessments, root cause analyses, and implement effective CAPAs. - Coordinate cross-functional teams to ensure timely resolution of quality issues. - Drive continuous improvement initiatives based on NC trends and quality metrics. - Support internal and external audits and maintain compliance with the Quality Management System (QMS). - Contribute to, quality reporting, and other QA projects as required. TASKS · Lead and drive Non-Conformance investigations related to component failures, finished goods failures, product returns, and other quality events. · Perform comprehensive impact assessments, root cause investigations (e.g., 5 Why, Fishbone), and define, implement, and verify the effectiveness of corrective and preventive actions (CAPA). · Coordinate cross-functional investigation teams to ensure timely closure of quality events and compliance with internal procedures and regulatory requirements. · Monitor and report NC metrics and trends, identifying opportunities for continuous improvement and systemic corrective actions. · Lead and execute cross-functional quality improvement projects to reduce recurring non-conformances and improve product and process quality. · Support the planning, execution, and response to internal Quality Management System (QMS) audits. · Act as Subject Matter Expert (SME) and/or provide backroom support during external audits and regulatory inspections. · Support continuous improvement of supplier qualification, supplier management, and incoming material inspection processes. · Support supplier quality activities, including supplier qualification, performance monitoring, Supplier Corrective Requests (SCRs), supplier investigations, and supplier audits. · Prepare, review, and maintain quality documentation, investigation reports, and monthly/quarterly quality trend analyses. · Participate in and moderate Quality Assurance and Corrective Action review meetings. · Collaborate closely with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and other departments to resolve quality issues and ensure product compliance. · Perform other quality-related duties and projects as assigned. REQUIREMENTS AND SKILLS Education: Bachelor’s degree in Engineering or Life Sciences Special Knowledge: Strong English skills, both written and spoken French and/or German, both written and spoken Good IT knowledge in MS office Personality: Excellent organization and communication skills Flexible and adaptable to change with ability to work under pressure Responsible, operate with integrity and teamwork Learning attitude and logical approach Professional Experience: At least 3 years of experience in Quality Assurance within Medical Device and/or Pharmaceutical fields is required